AcneEarly Phase 1NCT06992154
Role of Akkermansia Muciniphila in Acne Vulgaris
A Early Phase 1 study testing Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule in people with Acne, run by Medical University of South Carolina.
Trial summary
The project explores the use of Pendulum's Glucose Control, which contains a unique combination of probiotics, including Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis, to treat acne by improving gut health and reducing inflammation. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne
- What is being tested?
- Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Jan 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged 18 to 45 years.
- Individuals with clinically diagnosed moderate to severe acne vulgaris, determined using standardized scales like the Global Acne Grading
- System (GAGS) by Investigators of the study.
- Willingness to provide informed consent and adhere to study protocols, including follow-ups and sample collections.
Who cannot join
- Recent and/or current antibiotic use: Individuals who have used antibiotics or probiotics within the last three months, as these can alter gut microbiota composition
- Chronic gastrointestinal conditions: Participants with chronic gastrointestinal conditions such as Chron's disease, ulcerative colitis or irritable bowel syndrome (IBS).
- Immune disorders: Individuals with known immune deficiencies or autoimmune diseases, which might affect inflammation levels and study outcomes.
- Pregnancy or Lactation: pregnant or breastfeeding women, due to potential risk and hormonal changes that could influence acne and gut health.
- Inability or unwillingness of subject or legal guardian/representative to give informed consent
- Oral acne medications, including isotretinoin and spironolactone: these medications can significantly alter acne severity, making it difficult to isolate and accurately measure the effects of the probiotic intervention. Isotretinoin, a powerful retinoid, and spironolactone, a hormone-modulating medication, both have well-documented impacts on acne that could confound the study's results. Excluding participants using these medications ensures that changes in acne severity can be more directly attributed to the probiotic being tested, leading to clearer, more reliable findings on its efficacy.
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- History of metabolic disorders such as type 1 diabetes (DM1) and type 2 diabetes (DM2): DM1 and DM2 and their therapies can significantly alter baseline metabolic markers, such as glucose levels, insulin sensitivity, and inflammatory responses. Including such individuals might confound the results and make it difficult to attribute observed effects solely to the probiotics.
- Chronic gastrointestinal conditions: Participants with chronic gastrointestinal conditions such as Crohn's disease, ulcerative colitis or irritable bowel syndrome (IBS).
- Known hypersensitivity to >4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin
- Known hypersensitivity to >4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin
- Known allergy or hypersensitivity to any of the following ingredients: Akkermansia muciniphila, Anaerobutyricum hallii, Bifidobacterium infantis, Clostridium beijerinckii, and Clostridium butyricum Other Ingredients: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate (flow agent for encapsulation), and silica.
- Immune disorders: Individuals with known immune deficiencies or autoimmune diseases, which might affect inflammation levels and study outcomes.
- BMI of greater than or equal to 45: Excess adiposity is likely to impact sex hormones, inflammation, insulin resistance, and GLP-1 levels. These factors could confound the study outcomes. Additionally, excess adiposity is associated with hyperandrogenism and changes in sex hormone-binding globulin (SHBG), which may independently influence acne severity and skew results.
About this study
Official title: Acne Treatment With Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule to Impact Metabolic Health
The project explores the use of Pendulum's Glucose Control, which contains a unique combination of probiotics, including Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis, to treat acne by improving gut health and reducing inflammation. These probiotic strains work synergistically to enhance the gut's protective barrier, lower harmful substances such as lipopolysaccharides, and increase the production of beneficial compounds like short-chain fatty acids, which can help modulate immune response and inflammation associated with acne. By integrating this probiotic combination into treatment strategies, the approach aims to offer a natural and effective solution for clearer skin. Additionally, the project seeks to investigate the correlation between postprandial glucose spikes and acne flare-ups. Continuous glucose monitoring (CGM) will be employed to track blood glucose fluctuations following meals, providing valuable insights into the potential link between metabolic responses and acne severity. This comprehensive approach aims to enhance understanding of how gut health, inflammation, and metabolic factors interact in the context of acne management.
Read the detailed description
Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis are emerging as promising candidates for next-generation probiotics with potential applications in the management of acne. These microorganisms have been recognized for their roles in enhancing gut barrier function and contributing to a healthy gut microbiota composition. Through mechanisms such as strengthening the gut mucosal barrier and reducing systemic lipopolysaccharide levels, these probiotics may help mitigate systemic inflammation and lower inflammatory markers. Additionally, their capacity to produce short-chain fatty acids, including acetate, propionate, and butyrate, may contribute to immune modulation and a reduction in inflammatory processes, which are relevant to acne pathogenesis. This evidence highlights the potential utility of these probiotics in therapeutic strategies aimed at improving acne outcomes via modulation of the gut microbiota.
In this study, investigators also aim to explore the relationship between postprandial glucose spikes and acne flare-ups. To investigate this, investigators will utilize continuous glucose monitoring (CGM) to track fluctuations in blood glucose levels following meals. By correlating these glucose spikes with changes in acne severity, investigators hope to gain a deeper understanding of the potential connection between metabolic responses and inflammatory skin conditions. This approach will provide valuable insight into how dietary factors and gut microbiota modulation may interact to influence acne outcomes.
- Conditions
- Acne
- Being tested
- Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic CapsuleDietary supplement
Probiotic capsule will contain Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, and Bifidobacterium Infantis
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Participants will receive a 12-week probiotic course. Receives: Dietary Supplement: Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne severity reduction
The primary outcome measure will be the reduction in acne severity from baseline, as assessed by a validated acne severity scoring system (the Global Acne Grading System). Acne severity will be evaluated based on the number, type, and distribution of lesions, as well as the overall clinical assessment of the skin condition. Assessments will be conducted at baseline and specified follow-up intervals to determine the extent of improvement. Reduction in severity will be quantified as a percentage change from baseline scores.
Measured: 12 weeks
Secondary outcomes (1)
Association Between Postprandial Glucose Spikes and Acne Flares
The secondary outcome measure will evaluate the association between postprandial glucose spikes and the frequency or severity of acne flares. Postprandial glucose levels will be monitored using continuous glucose monitoring at designated intervals. Acne flares will be assessed using a validated acne severity scoring system along with participant journals, with flare frequency and changes in lesion count/type recorded over the study period. Correlations between glucose spike magnitude and acne flare characteristics will be analyzed to identify potential relationships.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startMar 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Pendulum Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992154
- Sponsor's protocol ID
- Pro00137381
- Status last verified
- May 2026
- First submitted
- 19 May 2025
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acne Treatment With Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule to Impact Metabolic Health
- ClinicalTrials.gov ID
- NCT06992154
- Acronym / sponsor ID
- Pro00137381
- Conditions
- Acne
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Pendulum Therapeutics
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project explores the use of Pendulum's Glucose Control, which contains a unique combination of probiotics, including Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis, to treat acne by improving gut health and reducing inflammation. These probiotic strains work synergistically to enhance the gut's protective barrier, lower harmful substances such as lipopolysaccharides, and increase the production of beneficial compounds like short-chain fatty acids, which can help modulate immune response and inflammation associated with acne. By integrating this probiotic combination into treatment strategies, the approach aims to offer a natural and effective solution for clearer skin. Additionally, the project seeks to investigate the correlation between postprandial glucose spikes and acne flare-ups. Continuous glucose monitoring (CGM) will be employed to track blood glucose fluctuations following meals, providing valuable insights into the potential link between metabolic responses and acne severity. This comprehensive approach aims to enhance understanding of how gut health, inflammation, and metabolic factors interact in the context of acne management.
Detailed description
Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis are emerging as promising candidates for next-generation probiotics with potential applications in the management of acne. These microorganisms have been recognized for their roles in enhancing gut barrier function and contributing to a healthy gut microbiota composition. Through mechanisms such as strengthening the gut mucosal barrier and reducing systemic lipopolysaccharide levels, these probiotics may help mitigate systemic inflammation and lower inflammatory markers. Additionally, their capacity to produce short-chain fatty acids, including acetate, propionate, and butyrate, may contribute to immune modulation and a reduction in inflammatory processes, which are relevant to acne pathogenesis. This evidence highlights the potential utility of these probiotics in therapeutic strategies aimed at improving acne outcomes via modulation of the gut microbiota.
In this study, investigators also aim to explore the relationship between postprandial glucose spikes and acne flare-ups. To investigate this, investigators will utilize continuous glucose monitoring (CGM) to track fluctuations in blood glucose levels following meals. By correlating these glucose spikes with changes in acne severity, investigators hope to gain a deeper understanding of the potential connection between metabolic responses and inflammatory skin conditions. This approach will provide valuable insight into how dietary factors and gut microbiota modulation may interact to influence acne outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic CapsuleParticipants will receive a 12-week probiotic course. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants aged 18 to 45 years.
- Individuals with clinically diagnosed moderate to severe acne vulgaris, determined using standardized scales like the Global Acne Grading
- System (GAGS) by Investigators of the study.
- Willingness to provide informed consent and adhere to study protocols, including follow-ups and sample collections.
Key exclusion criteria (13 listed)
- Recent and/or current antibiotic use: Individuals who have used antibiotics or probiotics within the last three months, as these can alter gut microbiota composition
- Chronic gastrointestinal conditions: Participants with chronic gastrointestinal conditions such as Chron's disease, ulcerative colitis or irritable bowel syndrome (IBS).
- Immune disorders: Individuals with known immune deficiencies or autoimmune diseases, which might affect inflammation levels and study outcomes.
- Pregnancy or Lactation: pregnant or breastfeeding women, due to potential risk and hormonal changes that could influence acne and gut health.
- Inability or unwillingness of subject or legal guardian/representative to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic CapsuleProbiotic capsule will contain Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, and Bifidobacterium Infantis | Dietary supplement | Probiotic Group |
Primary outcome
Acne severity reduction
Time frame: 12 weeks
The primary outcome measure will be the reduction in acne severity from baseline, as assessed by a validated acne severity scoring system (the Global Acne Grading System). Acne severity will be evaluated based on the number, type, and distribution of lesions, as well as the overall clinical assessment of the skin condition. Assessments will be conducted at baseline and specified follow-up intervals to determine the extent of improvement. Reduction in severity will be quantified as a percentage change from baseline scores.
1 secondary outcome
Association Between Postprandial Glucose Spikes and Acne Flares
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule in people with Acne, run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne severity reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.